A Validation Lead is hired to handle quality control and to validate various types of technologies and equipment. Typical work activities found on the Validation Lead Resume are – collaborating with engineers and other departments, reporting to senior management, monitoring all systems and units and ensuring its qualification to be validated, managing qualification program in accordance to necessary protocol, evaluating all data, ensuring implementation of all qualification, reviewing and approving preventive maintenance and critical systems, and training various departments.
Those seeking this job role should be able to demonstrate on the resume the following skills – technical skills, computer proficiency, multitasking skills, project management skills, networking skills, operational knowledge of data collection, exceptional knowledge of all rules and standards, skilled to interpret all validation requirements; and proficiency in understanding all guidelines for GMP facilities. Employers pick resumes that highlight a bachelor’s degree in biotechnology, or process controls.
Objective : Dynamic Validation Lead with over 2 years of experience in computer systems validation and regulatory compliance. Proficient in executing validation protocols and ensuring adherence to quality standards within life sciences. Committed to driving process improvements and delivering results that align with organizational objectives.
Skills : Ms Office Suite, Validation Planning, Data Integrity, Regulatory Compliance
Description :
Executed validation projects to ensure compliance with J&J Quality standards for legacy Computer Systems Applications.
Engaged in validation efforts for diverse systems, including Track-IT Help Desk and eSAAF.
Authored Compliance Analysis Reports to document system applications and relevant regulations.
Developed Compliance Plans outlining the approach to software engineering quality principles.
Led validation activities for pharmaceutical products, ensuring compliance with regulatory standards.
Collaborated with R&D Project Core Team to integrate user needs into validation strategies.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Junior Validation Lead Resume
Objective : Dedicated professional with 2 years of experience in validation within regulated environments. Skilled in executing validation plans, conducting risk assessments, and ensuring compliance with industry standards. Passionate about enhancing quality processes and delivering impactful results that meet organizational goals.
Played a crucial role in developing and delivering innovative therapies for patients with rare diseases.
Participated in the implementation and validation of the ValGenesis system, enhancing validation processes.
Generated validation deliverables in accordance with company standards using an electronic management system.
Developed a detailed Validation Plan for the ValGenesis system to ensure compliance.
Assembled a Risk Analysis team to perform requirement-level risk assessments and develop mitigation strategies.
Engaged in knowledge exchange with cross-functional teams to improve software solutions.
Provided insights into validation processes, contributing to continuous improvement initiatives.
Experience
0-2 Years
Level
Junior
Education
B.S. Biology
Validation Lead Resume
Headline : Proficient Validation Lead with 7 years of expertise in computer systems validation and regulatory compliance within life sciences. Adept at steering validation efforts, enhancing quality protocols, and ensuring adherence to industry standards. Eager to leverage my skills for impactful results that drive organizational success.
Skills : Validation Management, Problem Solving, Time Management, Communication Skills, Attention To Detail, Analytical Thinking
Description :
Implemented Labware LIMS in GQAD, enhancing data integrity and compliance.
Led computer system validation and implementation activities, ensuring regulatory adherence.
Monitored project timelines and objectives, driving accountability and results.
Prepared and updated the GQAD LACES Project Charter to align with strategic goals.
Recommended best practices and technologies for LIMS implementation in GQAD.
Reviewed system design and architecture documents to ensure validation integrity.
Authored a comprehensive Master Validation Plan to streamline validation processes.
Experience
5-7 Years
Level
Senior
Education
B.Sc. Biochemistry
Validation Lead Consultant Resume
Objective : Accomplished Validation Lead Consultant with 5 years of expertise in computer systems validation and regulatory compliance within the pharmaceutical sector. Proven track record in developing and executing validation protocols, enhancing quality assurance processes, and ensuring regulatory adherence. Passionate about driving efficiency and contributing to organizational success through innovative validation strategies.
Oversaw and approved documentation and testing activities of Quality Systems to align with client and IT management goals.
Validated multiple in-house developed applications, ensuring comprehensive documentation of deliverables.
Coordinated project assignments with technical communicators to enhance efficiency.
Reviewed and approved documentation in accordance with Lilly Quality Standards and Protocols.
Engaged in retrospective validation and documentation efforts for key applications.
Supported customers during validation execution, ensuring alignment with their requirements.
Tracked product features and workflow issues, providing actionable insights for continuous improvement.
Experience
2-5 Years
Level
Consultant
Education
B.S. Biotech
Validation Lead Resume
Summary : Seasoned Validation Lead with 10 years of extensive experience in computer systems validation and regulatory compliance within life sciences. Expert in developing and executing validation strategies that enhance quality assurance protocols. Dedicated to driving operational excellence and fostering compliance to ensure organizational success.
Executed comprehensive validation of Service Now applications using QTP and QCALM, ensuring full compliance with regulatory standards.
Configured Service Now tools to meet specific organizational requirements, enhancing operational efficiency.
Developed and maintained validation documentation, including RTM, Test Plans, and Validation Summary Reports, ensuring clarity and traceability.
Conducted backend testing using SQL TOAD and RestClient, ensuring data integrity and application performance.
Collaborated with stakeholders to diagnose issues and recommend effective solutions, fostering strong communication across teams.
Installed and configured software production environment replicas for rigorous performance testing.
Ensured all deliverables complied with Healthineers policies, achieving high standards of quality and regulatory compliance.
Experience
7-10 Years
Level
Management
Education
B.S. Biology
Validation Lead Specialist Resume
Headline : Accomplished Validation Lead Specialist with 7 years of experience in computer systems validation and compliance in regulated environments. Expertise in developing validation protocols, ensuring adherence to quality standards, and driving process enhancements. Committed to leveraging analytical skills to optimize validation processes and ensure organizational success.
Ensured compliance of standard operating procedures (SOPs) and validation documents with internal policies and cGMP guidelines.
Developed and managed comprehensive testing strategies, including test plans, schedules, and defect management processes.
Validated the EDC 2.0 system and ensured all documentation met regulatory compliance standards.
Oversaw the compliance of validation documentation including OQ, PQ, and software validation protocols.
Coordinated regression testing across external applications while managing diverse test environments.
Evaluated 21 CFR Part 11 requirements to enhance data security protocols and electronic signatures.
Conducted integrated data testing using SQL and prepared comprehensive proof of testing documents.
Experience
5-7 Years
Level
Senior
Education
B.S. Biology
Validation Lead Resume
Summary : Accomplished Validation Lead with 10 years of experience in computer systems validation and regulatory compliance. Expertise in developing and implementing robust validation strategies that ensure quality standards and regulatory adherence. Passionate about driving process optimization and fostering a culture of continuous improvement to achieve organizational excellence.
Skills : Regulatory Compliance Expertise, System Validation, Process Validation, Validation Strategy, Cross-functional Collaboration, Root Cause Analysis
Description :
Designed comprehensive test plans and validation protocols to ensure compliance with regulatory standards.
Executed system modifications and conducted thorough testing to facilitate successful implementation.
Integrated user acceptance testing and regression testing programs to enhance system reliability.
Documented and tracked software defects to ensure timely resolution and compliance.
Identified and analyzed program functional issues, documenting findings to support continuous improvement.
Planned and coordinated testing schedules aligned with project milestones and delivery dates.
Facilitated user and third-party testing to validate system functionality and performance.
Experience
10+ Years
Level
Executive
Education
MSQA
Validation Lead Analyst Resume
Objective : Results-oriented Validation Lead Analyst with 2 years of experience in validating systems and ensuring compliance in regulated environments. Adept at implementing validation protocols and enhancing quality assurance processes to meet industry standards. I am dedicated to driving efficiency and ensuring successful project outcomes that align with organizational goals.
Reviewed and approved validation and qualification documents to support manufacturing systems, including equipment and process validations.
Ensured adherence to client policies and regulatory standards throughout all validation activities.
Developed comprehensive validation strategies aligned with project goals and industry best practices.
Implemented quality systems to monitor and enhance product and process integrity.
Evaluated validation documentation to ensure compliance with FDA and other regulatory requirements.
Participated in change control processes, ensuring proper validation of modifications.
Collaborated with cross-functional teams to drive continuous improvement in validation practices.
Experience
0-2 Years
Level
Fresher
Education
B.S. Biology
Validation Lead Resume
Summary : Accomplished Validation Lead with a decade of expertise in overseeing computer systems validation and ensuring regulatory compliance. Skilled in developing comprehensive validation frameworks and driving quality assurance initiatives across life sciences. Committed to fostering continuous improvement and operational excellence, aligning validation processes with strategic objectives.
Skills : Hp Quality Center Alm, Soap Ui Testing, Jira Project Management, Process Improvement, Change Control, Validation Protocols
Description :
Designed and executed validation plans for systems in compliance with 21 CFR Part 11 and GxP guidelines.
Reviewed and validated test scripts, ensuring adherence to industry standards and regulatory requirements.
Documented and managed defects in HP Quality Center, facilitating effective resolution tracking.
Developed Change Requests and Incident Reports, improving communication and documentation processes.
Conducted performance testing across multiple applications, ensuring optimal system functionality.
Generated comprehensive testing progress and defect reports for stakeholder review and decision-making.
Collaborated with cross-functional teams to enhance validation methodologies and practices.
Experience
7-10 Years
Level
Management
Education
MS QA
Validation Lead Resume
Objective : Validation Lead with 5 years of experience in computer systems validation and regulatory compliance within the life sciences sector. Expert in executing validation strategies, ensuring adherence to quality standards, and enhancing operational efficiency. Driven to implement innovative solutions that promote compliance and support organizational goals.
Skills : Technical Documentation, Training Development, Team Leadership, Compliance Audits, Risk Mitigation, Validation Planning
Description :
Led a team to develop Operational Qualification Protocols for USP Water Systems, enhancing production capacity through effective validation strategies.
Diagnosed and resolved issues in PLC Ladder Logic Programming, ensuring alignment with Functional Specifications.
Authored and updated Operational and Preventive Maintenance SOPs to improve compliance and efficiency.
Reviewed SDLC documentation for utilities and equipment, ensuring compliance with validation standards and 21 CFR Part 11.
Conducted comprehensive reviews of change control documents and deviations for biotechnology equipment to maintain quality standards.
Developed and executed necessary documentation for validation projects, ensuring thorough compliance.
Performed extensive functional and regression testing on applications to verify system functionality and compliance with quality standards.
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